Methods and systems for labeling labware

ABSTRACT

The present invention includes a system for marking labware. The system includes an instruction set with markings to be applied to pieces of labware and the order in which the markings are to be applied to the labware. The system also includes a marking device that receives the instruction set and then places the non-toxic marks on the pieces of labware. The invention also includes methods tracking chain of custody of biological material in a facility. The methods include assigning a unique marking for biological materials, storing that marking in a database, applying a non-toxic marking to a piece(s) of labware and then scanning the marking.

CLAIM OF PRIORITY

This application is a continuation of utility application Ser. No.13/271,507, filed on Oct. 12, 2011, now U.S. Pat. No. 8,965,795, issuedFeb. 24, 2015, which in turn claims the benefit of provisionalapplication 61/392,060, filed on Oct. 12, 2010.

FIELD OF THE INVENTION

The invention relates to systems and methods for labeling labware, andmore particularly, to systems and methods for labeling labware whilemaintaining a sterile environment.

BACKGROUND OF THE INVENTION

In vitro fertilization (IVF) is an important technique for providingfamily planning options. Although a relatively mature area of science,in practice IVF remains expensive and stressful for people.Consequently, IVF personnel are extremely conservative is the adoptionof new technologies. In particular, personnel refuse to adopt anytechnology that could have an adverse effect on the success of an IVFprocedure, either through the procedure itself or through theintroduction of materials that may be toxic. This reticence extends toevery aspect of the procedure including the tools and technologies thatplay a supporting role in the IVF procedure.

The recent focus on the high cost of health care has placed pressure onall personnel to reduce overhead. Reducing overhead includesstreamlining the record keeping. However, the extreme reticence of IVFpersonnel has lead most personnel to not adopt techniques that wouldreduce recording keeping costs because of concerns that introducing newtechnology will introduce new dangers.

One area of concern is the tracking of biological material such asgamete and embryo materials. Since no mistakes are acceptable, there ishigh importance placed on accurately tracking materials in the fertilityclinic and laboratories. These materials typically are handled byseveral personnel and are moved from location to location multiple timeswithin the facility. Thus, there are several chances for mistakes to bemade.

This has led fertility clinics and laboratories to permanently markcontainers, such as culture dishes and other labware. Predominately,labware is hand-marked with a carbide tipped stylus. The markings on theculture dishes are often repeated on the top (lid) of the dish and onthe bottom of the dish and the markings consist of anywhere from 10-100characters (approximately). Hand engraving the culture dishes consumesthousands of hours of staff time. Hand engraving is open to errors induplication because the engraving has to be completed up to twenty timesfor each procedure. Moreover, this process is usually completed in asterile environment and thus is not amenable to completion by lesstrained staff and is usually completed by an embryologist or laboratorytechnician, so as to preserve the sterile, non-toxic environment of thedishes and the laboratory.

The present invention overcomes one or more of these problems.

SUMMARY OF THE INVENTION

The present invention includes a system for marking labware. The systemincludes an instruction set with markings to be applied to pieces oflabware and the order in which the markings are to be applied to thelabware. The system also includes a marking device that receives theinstruction set and then places the non-toxic marks on the pieces oflabware. The invention also includes methods tracking chain of custodyof biological material in a facility. The methods include assigning aunique marking for biological materials, storing that marking in adatabase, applying a non-toxic marking to a piece(s) of labware and thenscanning the marking.

DETAILED DESCRIPTION

The present invention includes a system for the addition of a non-toxicmarking on labware.

Labware includes all containers that may be utilized in a clinical orlaboratory environment. Labware is a general term that encompassescontainer that are made of glass, plastic, metal, etc. Exemplary labwareincludes culture dishes that included a top or lid and a bottom, as wellas sample vials and test tubes and their associated caps or covers.Labware also includes wrist bands utilized to identify clients duringclient visits to the facility. While labware generally includes onlysingle use or disposable containers, multiuse containers are alsocontemplated.

Non-toxic generally means that the success of the IVF or other medical,surgical, diagnostic or research procedures performed in the facilitywill not be adversely effected by the introduction or presence of themarking. Non-toxicity can be shown through FDA approval, manufacturercertification or other means.

The system includes at least an instruction set and a marking device.

The instruction set is information that is useable by the marking deviceto apply one or more markings to labware. The instruction set includesinformation about the nature of the marking to be applied, the type ofmaterial that makes up the particular piece of labware, the positioningof the marking on a particular piece of labware, and positioning of aparticular piece of labware within a work area of the marking device.

The marking includes both human readable and non-human readablemarkings. Human readable markings may include information, such asclient name, social security number, birth date, medical record number(MRN), donor record number, third party reproduction information,specimen number, specimen ID, etc. Non-human readable markings includebarcodes. Barcodes include all one, two and three dimensional markingsthat may be visible to the naked eye and/or read with a scanner andpreferably with an optical scanner. Barcode also includes a string ofinformation that may be read with a radio frequency scanner. Forexample, RFID tags may include barcodes in the information that theystore and/or transmit. Barcodes are utilized because they are easilyassociated with specific client information and need to be assigned onlyonce. Barcodes also tend to contain a plethora of information in arelatively small space, and yet are reliably reproducible.

In a preferred embodiment, a two-dimensional or matrix barcode isutilized that is visible to the naked eye and readable by an opticalscanner. The 2D barcode includes a pattern of opaque cells or modulesarranged on the labware. The data to be encoded can be text (no matterwhat script or language) or numbers and the data size ranges from a fewbytes up to several thousand bytes. The amount of the encoded datadepends on the type of symbol used in the barcode (e.g. square,triangles, hexagon, circles, etc.), the number of symbols used andwhether different colors of symbols are utilized. The 2D barcode maystores 2,335 or more alphanumeric characters. However, a barcode storingbetween 12 and 24 alphanumeric characters is preferred because it isrelatively small in area and yet contains enough information to identifythe biological material in the labware.

In one embodiment for use in fertility facilities, the data encoded inthe 2D barcode is a marriage of identifying information about the femalegametes and the male gametes. The identifying information may includethe MRN, source record number, other information that uniquelyidentifies the source of the gametes, or other information that uniquelyidentifies the source record of the gametes. In one example, the femaleMRN and the male MRN are concatenated together to produce theinformation that would then be used to make the 2D barcode. On occasion,the information used to make the barcode is too voluminous to produce abarcode that will be appropriately sized for the piece of labware. Thus,a subset of information may be used, provided that the subset ofinformation still results in a unique barcode. Moreover, information mayused in the barcode concerning one set of gametes that is thecombination MRNs of multiple people; for example, when a same-sex malecouple both donate gametes to be used with a donated female gamete.Moreover, the process of generating the barcode may be reversible sothat the individual MRNs (or other identifying information) areretrievable. In this manner, a found piece of labware can be properlyassociated with any individual(s). Thus, the chain of custody of a pieceof labware is always available or reproducible, thus reducing oreliminating errors in the facility.

Error correction information may be added to the information from whichthe barcode is created, so that even if a portion (e.g. up to 40%) ofthe barcode is damaged, the information can still be retrieved from thebarcode.

The marking, particularly the human readable portion, may be modifieddepending on the type of labware that is being marked. For example, onlya partial client name may be used on space constrained labware. Thenon-human readable information may also be modified in such an instance.For example, the amount of information encoded in the barcode may bereduced (e.g. reduced error correction information or reducedinformation identifying the biological material), thus permitting abarcode with a smaller area.

In one preferred embodiment, the marking includes a mirror image ofanother marking to be placed on a piece of labware. In this embodiment,the mirror image marking will appear in the proper orientation whenviewed or scanned through the side or the top of the piece of labware,e.g. a culture dish. This is desirable for the facility personnelbecause the marking can be read without having to raise the labwareoverhead to read the bottom of the labware or without having to flip thelabware over. Both actions could cause damage to the contents of thelabware.

The instruction set may include human readable markings, non-humanreadable markings or combination of these markings. The instruction setmay include the markings per se (e.g. images), may include informationneeded by the marking device to reproduce the markings on the labware,or combinations thereof.

The instruction set may also include information on the type of materialthat makes up the particular piece of labware, e.g. glass, metal orplastic. In this manner, settings appropriate for the particularmaterial may be utilized by the marking device. For example, the lasersettings for marking glass may be different from the laser setting formarking plastic (or even two different types of plastic). Matching themarking device settings to the particular material will help insure thatthe markings will be consistently readable.

The instruction set may also include information on the positioning ofthe marking on a particular piece of labware. For example, the placementof a marking on a culture dish will be different than placement on asample vial. Proper positioning information will help insure that themarkings will be consistently readable. While it is preferred thatmarkings are placed on roughly flat surfaces of labware, this is notalways possible because the available flat surface is too small or thereis no flat surface of the labware. For example, on a culture dish, themarking may be placed on the rim of the top or bottom plate. This wouldinsure that the marking would not hinder inspection of the contents ofthe dish (e.g. under a microscope). In an alternative, the marking canbe placed circumferentially along the edge of the top or bottom plate soas to provide a greater field of view.

The instruction set may also include information on the position ofindividual pieces of labware within the work area of the marking device.This permits batch marking of labware. A plurality of different markings(represent different clients of the facility) may be applied to a batchof identical pieces of labware (e.g. all culture dishes). A plurality ofthe same markings (representing the same client) may be applied a batchof various pieces of labware (e.g. culture dishes, sample vials, wristbands, etc.). Of course, different markings may be applied to a batch ofvarious pieces of labware.

The information in the instruction set may be organized so as toincrease the efficiency of the marking. For example, the informationcould be organized by client information so that all the labware for aparticular client's procedure is marked in a batch. In the alternative,the information could be organized by labware type so that labware ofthe same type is marked in a batch. In addition, other ways to organizethe information in the instruction set are also contemplated, such as byclient's scheduled appoint, by facility personnel, by procedure, etc.Being able to organize the instruction set for primacy of clientinformation and for primacy of labware type provides flexibility whilealso achieving economies of scale. Of course, the instructions set couldbe sorted to combine client information, labware type, client schedule,etc.

While not required, the present marking system may be used with sterilelabware, where sterile generally means that the environment is free ofpathogens. This is particularly, desirable in the fertility area, giventhe delicacy and expense of the procedure.

In one family of embodiments, the marking is a part of the labware suchas molded into the labware or engraved into the labware. In bothembodiments, labware would not needed to be opened during the markingprocess, thus preserving the sterility of the environment within thelabware.

The marking device may include a rotary or laser engravers. Thesemarking devices include a stylus, which is the portion of the devicethat physically modifies the labware. For a rotary engraver, the styluswould be like a drill bit or other rotating grinding tool. For a laserengrave, the stylus would be where the laser exits the device. These areparticularly well suited for use on labware because of the precisionwith which these devices can render markings. For example, the stylus ofthese engravers can render marking having up to 1200 dpi or more. Anengraver is suitable because, when connected to an appropriatelyprogrammed computer, it can reliably reproduce a marking (e.g. abarcode) across several pieces of labware as well as reliably produceinnumerable different markings on different pieces of labware. Engravingis a known and accepted non-toxic method of marking labware and does notintroduce any new materials into the procedure. The engraver is easilyscalable also permitting increased marking of labware as client volumesincrease. Furthermore, an engraver permits labware to be marked at thetime of use or onsite at the facility. This permits customization of themarking process to meet the needs of individual facilities.

Each marking device operates within reach of the stylus. This so calledwork area may be integrated into or separate from the rest of themarking device. The work area may simple be a predefined area on thework bench in which labware is placed to be marked. In the alternative,the work area may be a tray or other open, roughly-flat, container tosequester the labware from the remainder of the work bench. The workarea may include a mat, template or other material which help preventthe labware from moving during the marking operation. While not criticalfor a laser engraver, it is preferred for a rotary engraver. Forexample, a small-form, desktop model of an engraver, the work area thatcould hold four to eight 60×15 mm culture dishes at a time. A largerwork area could hold up to sixteen 60×15 mm dishes.

In one embodiment, a laser engraver is utilized. A laser engraver hasseveral advantages including being able to engrave multiple types ofmaterials such as glass and plastic. While any laser engraver capable ofwriting the barcode may be utilized, it is preferred that the laserengraver be capable of marking the labware without damaging the materialof the labware. For example, with a laser that is too powerful, plasticlabware will not be marked, but rather the laser will just melt theplastic, rendering the marking unreadable. Reducing the fidelity of thebarcode increases read error rates, and thus increases the cycle time ofreading the barcodes.

Moreover, it is preferred that the laser engraver include an opticssystem that permits a suitable balance between DPI and power of laserwhile limiting damage to the material of the labware. For example, onepreferred engraver is a CO2 laser engraver that utilizes the radiancehigh definition optics system found in some Epilog laser engravers.These lasers have a more perfectly circular shape to their beam,maintain that circular shape over the entire engraving operation, have asmall spot size, and have a higher power density. One preferred laserengraver is the Epilog Mini24 laser engraver system.

In another embodiment, the labware is manufactured with a barcode in thematerial of the labware. For example, barcodes (e.g. bumpy barcodes)could be molded into glass or plastic culture dishes at the time ofmanufacture. Such markings have the same ability to be used to trackchain of custody as engraved markings. The bumpy barcodes may or may notbe unique on each piece of labware. For example, there may be anadvantage to having several pieces of labware marked with the samebarcode. Bumpy barcodes would be non-toxic and thus non-controversialbecause they do not introduce any new materials into the procedure.

In a second family of embodiments, the barcode is attached to thelabware. Attachment includes adhesive attachment, embedding as well asusing a physical fastener.

In one embodiment, an RFID tag (including an integrated circuit and anantenna) may be adhesively attached to the labware. The RFID tag storesthe barcode and responds with the barcode when interrogated. In thealternative, an RFID tag may be embedded in the labware at the time ofmanufacturing. Placement of the RFID tag is preferably similar toplacement of the engraved barcode.

Any of active, passive or programmable RFID tags may be used, dependingon the non-toxicity of the RFID interrogator. One advantage of theembedded RFID tag over the bumpy barcode is that each piece of labwarecan be given a changeable barcode.

In another embodiment, a barcode is printed on paper and a non-toxicadhesive is applied to the paper or the labware, with the label thenattached to the labware. The paper may be sterile or otherwisesterilized prior to or after printing of the bar code. The labels may bepre-printed or printed on demand. Likewise, the label may have adhesivepre-applied or applied on demand. Such labels are easy to use becausethey can be applied without exposing the contents of the culture dish.Moreover, the adhesive can be placed on the printed side so that the barcode can be visualized through the bottom of the culture dish. Theselabels may be placed in a similar manner to the engraved barcodes.Exemplary labels with non-toxic adhesives are those provided under thename Zebra 8000T or HC10000688.

In another embodiment, a barcode on sterile paper is attached to thelabware with a physical fastener such as wire or zip tie. A loop locatedon the piece of labware, e.g. one or both of the top and bottom of theculture dish, may be used to attached the paper label to the labware.The wire or zip tie are preferably made of known non-toxic materials andare easily sterilizable or otherwise easy to maintain in a sterilecondition.

In addition to an instruction set and a marking device, systems of thepresent invention may also include additional components such that thesystem is useful in providing a chain of custody for biological materialused in procedures at the facility. Chain of custody of biologicalmaterial is of critical importance in the medical field in general andespecially in the fertility field because errors have lifelong and lifealtering consequences.

One or more scanners may be used to enhance the chain of custodytracking ability of the system. Suitable scanners include those that arecapable of reading the non-human readable markings created by themarking device. Suitable scanners include those that capture or respondto reflected energy. Exemplary devices may include imaging sensors suchas photodiodes, charge-coupled devices, contact image sensors,photomultiplier tubes, etc. In one embodiment, the scanner also providesa source of energy, such as a laser or other visible light so that thescanner is the source of the energy that is then reflected back andcaptured by the scanner. In another embodiment, the scanner responds toreflected ambient energy.

For visible barcodes, optical scanners will accomplish this task. ForRFID tags, a RF scanner will accomplish this task. While the scanner mayalso read the human readable marking on the labware, this is notrequired. Indeed, the complexity and cost of the scanner can be reducedby excluding this functionality. Optical scanners (and thus visiblebarcodes) are preferred because the light recognized by these scannersis generally accepted as non-toxic. While unclear whether there is anissue, questions surround the safety of using ultraviolet or radiofrequency scanners in connection with biological material. By using ascanner that is generally considered safe, acceptance of the scanner bythe profession will be increased. Exemplary scanners include those fromCognex and the 8000 series in particular for culture dishes, vials, etc.and a 750 series for paperwork, etc.

In addition to the scanner, the system may also include software withone or more of the following components: a database component, a markingcomponent and scanning component (communicates with the database totrack the barcode). The database component will store the neededinformation for producing the instruction set. In addition, the databasealso contains information regarding the client's scheduled procedure atthe facility. Associated with each procedure is a labware countdetailing the type and number of culture dishes, vials, etc. needed forthat procedure or client.

Based on the client identifying information and procedure information,the instruction set for the engraver can be produced by the markingcomponent. While usually separate from the database component, thefunctionality of the marking component may never the less be carried outby the data base component. Likewise, while typically part of themarking component, the functionality of creating the barcode may be partof the database component or a separate component altogether. Theinstruction set generated by the marking component is structured so thata print driver for the marking device can pass the instructions in theinstruction set to the marking device.

The software for the system may be any stock or custom programs or setof programs running on an appropriately programmed general purposecomputer. For example, an Access database running on the windowsoperating system would be a suitable database component.

The scanning component of the software communicates the information readby the scanner to the database component, where the information may bestored, further manipulated or otherwise acted upon.

In one preferred embodiment, some or all of the labware for one client'sprocedure is loaded into the marking device in one batch and marked.Here, the instruction set would also include the arrangement of themyriad of labware pieces in the marking device's work area. In anotherembodiment, the information from several clients is gathered togetherinto the instruction set. In this manner, only one type of labware (e.g.culture dishes) are loaded into the area and marked in one batch.

Methods according to the presenting invention include assigning amarking to a client of a facility, storing that marking in a databaseconnected to a marking device, applying the marking to a piece oflabware with the marking device, and scanning the marking on the pieceof labware.

EXAMPLES Example 1

A sample database of 23 test clients was used for testing the markingdevice and scanner. Although some testing was completed using shorterlast names, to emulate the “real-world” data as accurately as possible,about half the dish markings included longer and hyphenated, last names.

An Epilog 24 mini 30 watt laser engraver, with radiance high definitionoptics, was utilized for the marking. Basic settings included using autofocus, a resolution of 200 dpi on a raster setting with the power set at20% and the speed set at 10%.

A Cognex DataMan 8500 series optical scanner was utilized for thescanning. Basic settings including using all light pipes with light pipeand bright field intensity set to the maximum.

Laser Marking Details and Scanner Results

Dish size Dish part # marked Time elapse Scan Results 60 × 15 mm top 304:32 (9.1/dish) No errors 60 × 15 mm bottom 30 4:32 (9.1/dish) No errors60 × 15 mm top 35 5:44 (9.8/dish) No errors 60 × 15 mm bottom 35 5:44(9.8/dish) No errors

Example 2

Dish size Dish part # marked Time elapse Scan Results 100 × 20 mm top 153:35 (14.3/dish) No errors 100 × 20 mm bottom 15 3:33 (14.3/dish) Noerrors 100 × 10 mm top 15 3:34 (14.3/dish) No errors 100 × 10 mm bottom15 3:33 (14.3/dish) No errors

As can be seen, marks made using 200 DPI and 20% power were fullyreadable by the scanner.

The next example was conducted to provide a baseline for the speed andreliability of scanning.

Example 3 60×15 mm Dishes (Tops and Bottoms) Non-Welled

Conditions: normal—constant ambient air temperature of 76 F (58 C)

Scanning duration: 12 minutes

Number scanned: top of 100 dishes

Scanner Results: 100% read rate with no errors (non-reads)

The next four examples were conducted to evaluate the effects ofcondensation, as it relates to the readability of the markings. Thecondensation condition for the examples were created by exposing thedishes to extreme temperatures, but the intent was to emulate anycondensation that may occur in the facility, as the dishes are movedfrom the incubators to the ambient air temperature. It was found that afreeze-thaw type scenario created more “extreme” conditions; thusproviding a better level of condensation, to test the scanning of themarked labware.

Culture dishes with condensation, created with freeze/thaw conditions.These dishes were stored at 0 F (−18 C) for 30 minutes, then exposure toambient air, prior to scanning the marks.

Example 4 100×20 mm Dish (Top and Bottom) Non-Welled

Conditions: 0 F (−18 C) for 30 minutes, then exposure to ambient air

Scanning duration: 5 minutes

Number scanned: top of 30 dishes

Scanner Results: 100% read rate with no errors (non-reads).

Example 5 60×15 mm Dish (Top and Bottom) Non-Welled

Conditions: 0 F (−18 C) for 30 minutes, then exposure to ambient air

Scanning duration: 4 minutes

Number scanned: top of 30 dishes

Scanner Results: 100% read rate with no errors (non-reads).

Example 6 60×15 mm Dish (Top and bottom) Welled

Conditions: 0 F (−18 C) for 30 minutes, then exposure to ambient air

Scanning duration: 4 minutes

Number scanned: top of 30 dishes

Scanner Results: 100% read rate with no errors (non-reads)

The next example was conducted to evaluate the effects of heavy mineraloil drops, as it relates to the readability of the laser markedbarcodes. Mineral oil is often used in combination with biologicalmaterial in labware. All marks were placed on the perimeter of thedishes and do not interfere with the viewing area of the dishes.

Example 7 100×15 mm Dish (Tops and Bottoms) Non-Welled with Oil Drops

Conditions: normal—constant ambient air temperature of 76 F (58 C)

Scanning duration: 6 minutes

Number scanned: tops of 30 dishes

Scanner Results: 100% read rate with no errors (non-reads)

As can be seen, the invention provides a system that can reliably marklabware and reliably read the marked labware. Reliable marking andscanning is critical to providing error free chain of custody needed ina facility.

As used in this specification, ‘read’, ‘scan’, ‘inspect’ and theirrelated forms all refer to visual inspection by facility personnel, withor without the aid of an external magnifier and also to the use of adevice which scans the labware for a markings such as an optical scanneror a RF scanner.

Furthermore, the present system may be expanded to include tracking ofpaper records, equipment and supplies and so it is contemplated that thescope of labware also includes these types of items. While differenttypes of marking devices may be utilized, such as document printers orlabel printers, the same marking may be used across all types of labwareto insure the chain of custody is maintained.

While the specification discusses the present invention in the contextof fertility facilities, it is contemplated that the systems and methodsmay be used in any facility, clinic or laboratory setting in which chainof custody of biological materials is important and it is contemplatedthat the definition of facility incorporates all of these situations.

It will be further appreciated that functions or structures of aplurality of components or steps may be combined into a single componentor step, or the functions or structures of one-step or component may besplit among plural steps or components. The present inventioncontemplates all of these combinations. Unless stated otherwise,dimensions and geometries of the various structures depicted herein arenot intended to be restrictive of the invention, and other dimensions orgeometries are possible. Plural structural components or steps can beprovided by a single integrated structure or step. Alternatively, asingle integrated structure or step might be divided into separateplural components or steps. In addition, while a feature of the presentinvention may have been described in the context of only one of theillustrated embodiments, such feature may be combined with one or moreother features of other embodiments, for any given application. It willalso be appreciated from the above that the fabrication of the uniquestructures herein and the operation thereof also constitute methods inaccordance with the present invention. The present invention alsoencompasses intermediate and end products resulting from the practice ofthe methods herein. The use of “comprising” or “including” alsocontemplates embodiments that “consist essentially of” or “consist of”the recited feature.

The explanations and illustrations presented herein are intended toacquaint others skilled in the art with the invention, its principles,and its practical application. Those skilled in the art may adapt andapply the invention in its numerous forms, as may be best suited to therequirements of a particular use. Accordingly, the specific embodimentsof the present invention as set forth are not intended as beingexhaustive or limiting of the invention. The scope of the inventionshould, therefore, be determined not with reference to the abovedescription, but should instead be determined with reference to theappended claims, along with the full scope of equivalents to which suchclaims are entitled. The disclosures of all articles and references,including patent applications and publications, are incorporated byreference for all purposes.

What is claimed is:
 1. A method of tracking movement of labwarecontaining biological materials in a facility, comprising: assigning aunique barcode to each of a plurality of biological materials, whereineach barcode identifies a source record for each biological material,wherein the source record comprises information about the identity orsource of the biological material; storing the barcode, or informationrepresenting the barcode, in a database connected to a laser engraver;engraving with the laser engraver at least one of the barcodes onto oneor more pieces of labware; scanning at least one barcode on at least onepiece of labware before or after transferring the at least one piece oflabware from one location to another.
 2. The method of claim 1 whereinone or more human readable markings is engraved in conjunction with thebarcode.
 3. The method of claim 2 wherein the source record of eachbiological material comprises: a) one or more medical record numbers, b)one or more source record numbers, c) information that uniquelyidentifies the source of the biological material, or 4) combinationsthereof.
 4. The method of claim 1 further comprising placing at leastone biological material into at least one piece of labware, eitherbefore or after the engraving step.
 5. The method of claim 4 furthercomprising repeating the scanning step at multiple locations.
 6. Themethod of claim 5 wherein the sterility of an interior space of the oneor more pieces of labware is maintained during the engraving step. 7.The method of claim 1 wherein error correction information is includedin the barcode.
 8. The method of claim 1 wherein the engraving stepfurther comprises engraving a mirror image of the barcode onto one ormore pieces of labware.